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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01218737 |
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Date of registration:
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08/10/2010 |
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Primary sponsor: |
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Public title:
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Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention of Ocular Infection/Inflammation
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Scientific title:
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Double-Masked, Randomized, Parallel Group Study for Evaluation of Non-Inferiority of 0.3%Gatifloxacin/1.0% Prednisolone Association Compared With Their Isolated Administration in the Prevention of Ocular Infection/Inflammation After LASIK Surgery |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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101 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01218737 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient is indicated to have an ocular refractive surgery performed (myopia,
astigmatism, hypermetropy) by the Lasik method.
- Patient presents a normal eye fundus.
- Patient has intraocular pressure (IOP) = 20 mmHg.
Exclusion Criteria:
- Surgery and/or previous ocular pathology (presence of scar/change in the cornea,
glaucoma, retinopathies, etc.).
- Patient has diabetes or is immunodepressed.
- Any systemic infection during the study.
- Signs and/or symptoms of ocular inflammation/infection (bacterial, viral, fungal,
caused by Chlamydia, by Mycobacterium, Acanthamoeba or of allergic etiology).
- Have used any systemic or topical antibiotics for ocular infection in the previous 14
days.
- Patient has known hypersensitivity to any of the components of the formulations used
in the study.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infection and Inflammation After Refractive Surgery (Lasik).
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Intervention(s)
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Drug: 0.3% gatifloxacin and 1.0% prednisolone acetate association
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Drug: isolated 0.3% gatifloxacin and 1.0% prednisolone acetate
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Primary Outcome(s)
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Percentage of eyes with absence of signs/symptoms of ocular infection/inflammation after surgery.
[Time Frame: Day 15]
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Secondary ID(s)
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AG9890X-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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